Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)
Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Sleep in critically-ill patients is commonly severely fragmented, and sleep architecture is altered as compared to a healthy person. This abnormal sleep may cause some important adverse psychological and physiological consequences. Noise, light, patient-care activities, pain, or medications are some of the contributing factors to sleep disruption in the ICU. Recent evidence also suggests that invasive mechanical ventilation (IMV) itself may lead to sleep fragmentation in the ICU. Noninvasive ventilation (NIV) is a well-established, relatively new form of ventilation which improves sleep quality or gas exchange in some patients with chronic hypoventilatory disorders. Although sleep may be disrupted due to discomfort from the mask or air leaking during NIV use; intermittent use of NIV may result in better sleep quality between NIV sessions. The effects of NIV on sleep in the acute care setting have not yet been studied.
The purpose of the study is to describe the sleep architecture of a cohort of critically-ill patients using NIV, comparing findings to a reference group of patients using (IMV).
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02111
- Tufts-New England Medical Center Medical ICU and Coronary Care Unit
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Age > 18 yrs
- Receiving invasive or noninvasive mechanical ventilation
- Anticipated further ventilation of at least 24-hour duration for IMV and 8 hours/ 24 hours for NIV
Exclusion Criteria:
- Pre-morbid diseases that could interfere with interpretation of sleep monitoring including CNS disorders (strokes, encephalopathic states), dementia, and known sleep disorders
- On home BiPAP or CPAP
- Depressed sensorium as evidence by Glasgow Coma Score < 10, need for continuous sedation with Riker Score < 2 and inability to follow verbal commands for sustained 3 hours
- Presence of head trauma, psychiatric illness (including use of antidepressant medication), anoxic brain injury, drug overdose or uncontrolled seizure disorder
- Severe hemodynamic instability (BP< 90 mmHg despite vasopressor therapy) and sepsis
- Recalcitrant hypoxemia (inability to sustain SaO2 > 88%)
- Considered as unstable by ICU team (hemodynamic instability, acute uncontrolled GI bleeding, acute cardiac ischemia or arrhythmias)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-control
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
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1
critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
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2
critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)
Tijdsspanne: During 24-hour monitorization period (after recruitment into the study)
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During 24-hour monitorization period (after recruitment into the study)
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To compare total sleep time and differences in sleep architecture including time spent in different sleep stages and arousals in critically-ill patients receiving mechanical ventilation in medical ICU and CCU
Tijdsspanne: During 24-hour monitorization
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During 24-hour monitorization
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To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking
Tijdsspanne: During 24-hour monitorization
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During 24-hour monitorization
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To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns
Tijdsspanne: During 24-hour monitorization
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During 24-hour monitorization
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To assess associations of severity of illness and sedation usage with sleep patterns
Tijdsspanne: During 24-hour monitorization period
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During 24-hour monitorization period
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Aylin Ozsancak, MD, research fellow
- Hoofdonderzoeker: Nicholas S Hill, MD, Chair of Pulmonary, Critical Care and Sleep Medicine Division
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB-8053
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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